Title:
Ultrasonic device for tissue ablation and sheath for use therewith
United States Patent 7503895
Abstract:
A transverse mode ultrasonic probe is provided which creates a cavitation area along its longitudinal length, increasing the working surface of the probe. Accessory sheaths are also provided for use with the probe to enable a user to select from features most suited to an individual medical procedure. The sheaths provide acoustic enhancing and aspiration enhancing properties, and/or can be used as surgical tools or as medical access devices, protecting tissue from physical contact with the probe.
US Patent References:
/0168975.html
Farmer - October, 1875 - 0168975

/0323762.html
White - August, 1885 - 0323762

/0404319.html
Taylor - May, 1889 - 0404319

/0414090.html
Taylor - October, 1889 - 0414090

/1045326.html
Ruflin - November, 1912 - 1045326


Inventors:
Rabiner, Robert A. (Chelmsford, MA, US)
Hare, Bradley A. (Chelmsford, MA, US)
Application Number:
10/373134
Publication Date:
03/17/2009
Filing Date:
02/24/2003
View Patent Images:
Assignee:
OmniSonics Medical Technologies, Inc. (Wilmington, MA, US)
Primary Class:
Other Classes:
600/439
International Classes:
A61B8/00; A61B8/14
Field of Search:
600/437, 606/169, 606/171, 600/459, 600/439
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5231080Method for the treatment of atherosclerosis, thrombosis, and peripheral vessel diseaseJuly, 1993Scholkens
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5300085Angioplasty apparatus facilitating rapid exchanges and methodApril, 1994Yock
5304115Ultrasonic angioplasty device incorporating improved transmission member and ablation probeApril, 1994Pflueger et al.604/22
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5304199Apparatus for arterial total occlusion plaque separationApril, 1994Myers
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5315996Torquable catheter and methodMay, 1994Lundquist
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5319278Longitudinal-torsional resonance ultrasonic motor with improved support structureJune, 1994Myohga et al.
5323902Safety device for holding and retaining hyposyringes and the likeJune, 1994Palmer et al.
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5324299Ultrasonic scalpel blade and methods of applicationJune, 1994Davison et al.606/167
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5330497Locking trocar sleeveJuly, 1994Freitas et al.
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5334167Modified nasogastric tube for use in enteral feedingAugust, 1994Cocanower
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5336234Method and apparatus for dilatation of a stenotic vesselAugust, 1994Vigil et al.
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5368558Ultrasonic ablation catheter device having endoscopic component and method of using sameNovember, 1994Nita604/22
5370602Phacoemulsification probe circuit with pulse width Modulating driveDecember, 1994Kepley
5380273Vibrating catheterJanuary, 1995Dubrul et al.604/22
5380274Ultrasound transmission member having improved longitudinal transmission propertiesJanuary, 1995Nita604/22
5382228Method and device for connecting ultrasound transmission member (S) to an ultrasound generating deviceJanuary, 1995Nita et al.604/22
5385372Luer connector with integral closureJanuary, 1995Utterberg
5387190Probe break detector for an ultrasonic aspiratorFebruary, 1995Gotanda et al.
5387197Trocar safety shield locking mechanismFebruary, 1995Smith et al.
5388569Phacoemulsification probe circuit with switch driveFebruary, 1995Kepley
5390678Method and device for measuring ultrasonic activity in an ultrasound delivery systemFebruary, 1995Gesswein et al.
5391144Ultrasonic treatment apparatusFebruary, 1995Sakurai et al.
5396902Steerable stylet and manipulative handle assemblyMarch, 1995Brennen et al.
5397293Ultrasonic device with sheath and transverse motion dampingMarch, 1995Alliger et al.601/2
5397301Ultrasonic angioplasty device incorporating an ultrasound transmission member made at least partially from a superelastic metal alloyMarch, 1995Pflueger et al.604/22
5402799Guidewire having flexible floppy tipApril, 1995Colon et al.
5403324Flexible catheter with stone basket and ultrasonic conductorApril, 1995Ciervo et al.
5405318Ultra-sound catheter for removing obstructions from tubular anatomical structures such as blood vesselsApril, 1995Nita604/22
5405341Catheter with multiple lumensApril, 1995Martin
5406503Control system for calibrating and driving ultrasonic transducerApril, 1995Williams, Jr. et al.
5409112Needle disposal system comprised of blood collection holder and companion biohazard receptacleApril, 1995Sagstetter
5417654Elongated curved cavitation-generating tip for disintegrating tissueMay, 1995Kelman604/22
5417672Connector for coupling an ultrasound transducer to an ultrasound catheterMay, 1995Nita et al.604/533
5419761Liposuction apparatus and associated methodMay, 1995Narayanan et al.604/22
5421338Acoustic imaging catheter and the likeJune, 1995Crowley et al.
5421829Ultrasonic surgical handpiece and an energy initiatorJune, 1995Olichney et al.
5423797Acoustic catheter with rotary driveJune, 1995Adrian et al.
5423838Atherectomy catheter and related componentsJune, 1995Willard
5425704Apparatus for generating ultrasonic oscillationJune, 1995Sakurai et al.
5427118Ultrasonic guidewireJune, 1995Nita et al.128/772
5429136Imaging atherectomy apparatusJuly, 1995Milo et al.
5431664Method of tuning ultrasonic devicesJuly, 1995Ureche et al.
5434827Matching layer for front acoustic impedance matching of clinical ultrasonic tranducersJuly, 1995Bolorforosh
5443443Atherectomy systemAugust, 1995Shiber
5443456Catheter with collapsible wire guideAugust, 1995Alliger et al.
5443457Tracking tip for a short lumen rapid exchange catheterAugust, 1995Ginn et al.
5443468Method for drilling a bore in bone using a compaction drillAugust, 1995Johnson
5445617Automatic retractable safety penetrating instrument for portal sleeve introduction and method of useAugust, 1995Yoon
5447509Ultrasound catheter system having modulated output with feedback controlSeptember, 1995Mills et al.606/1
5449369Flexible elongate device having a vibratory impact tip and method of its useSeptember, 1995Imran
5451233Angioplasty apparatus facilitating rapid exchangesSeptember, 1995Yock
5452611Ultrasonic level instrument with dual frequency operationSeptember, 1995Jones et al.
5454373Medical acoustic imagingOctober, 1995Koger et al.
5458584Intravascular catheter having an enclosed proximal end and a reduced profile distal regionOctober, 1995Ginn et al.
5458612Prostatic ablation method and apparatus for perineal approachOctober, 1995Chin606/192
5460595Multi-frequency ultrasound therapy systems and methodsOctober, 1995Hall et al.
5462530Intravascular catheter with bailout featureOctober, 1995Jang
5464016Medical acoustic imaging catheter and guidewireNovember, 1995Nicholas et al.
5464409Uterine manipulator and protectorNovember, 1995Mohajer
5464438Gold coating means for limiting thromboses in implantable graftsNovember, 1995Menaker
5467674Combined torque limiting and marking wrenchNovember, 1995Thorn
5469853Bendable ultrasonic probe and sheath for use therewithNovember, 1995Law et al.128/662.06
5470322Reinforced multilumen catheter for axially varying stiffnessNovember, 1995Horzewski et al.
5472441Device for treating cancer and non-malignant tumors and methodsDecember, 1995Edwards et al.606/41
5474075Brush-tipped catheter for ultrasound imagingDecember, 1995Goldberg et al.
5474530Angioplasty and ablative devices having onboard ultrasound components and devices and methods for utilizing ultrasound to treat or prevent vasospasmDecember, 1995Passafaro et al.
5474531Apparatus and method for enhanced intravascular phonophoresis including dissolution of intravascular blockage and concomitant inhibition of restenosisDecember, 1995Carter
5478353Suture tie device system and method for suturing anatomical tissue proximate an openingDecember, 1995Yoon
5478558Method of dissolving venous Thrombi using drug containing activated Protein CDecember, 1995Eibl et al.
5484398Methods of making and using ultrasonic handpieceJanuary, 1996Stoddard604/22
5492001Method and apparatus for working burred portion of workpieceFebruary, 1996Sasaki et al.
5498236Vibrating catheterMarch, 1996Dubrul et al.604/22
5501227Angioplasty apparatus facilitating rapid exchange and methodMarch, 1996Yock
5505714Non-rotational catheter compression clampApril, 1996Dassa et al.
5507738Ultrasonic vascular surgical systemApril, 1996Ciervo
5512037Percutaneous surgical retractorApril, 1996Russell et al.
5516043Ultrasonic atomizing deviceMay, 1996Manna et al.239/102.2
5524620Ablation of blood thrombi by means of acoustic energyJune, 1996Rosenschein
5524635Apparatus for advancing a guide wireJune, 1996Uflacker et al.
5527273Ultrasonic lipectomy probe and method for manufactureJune, 1996Manna et al.
5527279Control mechanism and system and method for steering distal extremity of a flexible elongate memberJune, 1996Imran
5531664Bending actuator having a coil sheath with a fixed distal end and a free proximal endJuly, 1996Adachi et al.
5536250Perfusion shunt device and methodJuly, 1996Klein et al.
5540656Ultrasonic angioplasty device having surface disruptionsJuly, 1996Pflueger et al.
5542917Ultrasound delivery catheters incorporating improved distal tip constructionAugust, 1996Nita et al.
5549563Reinforcing insert for uterine manipulatorAugust, 1996Kronner
5549576Vascular introducer valve with proximal self-lubricationAugust, 1996Patterson et al.
5562620Perfusion shunt device having non-distensible pouch for receiving angioplasty balloonOctober, 1996Klein et al.
5569276Intravascular catheter having combined imaging abrasion headOctober, 1996Jang et al.
5571014Disposable torque limiting wrenchNovember, 1996Gregory, Jr. et al.
5571085Steerable open lumen catheterNovember, 1996Accisano, III
5575772Albation cathetersNovember, 1996Lennox
5580962Parenterally administrable drug having thrombolytic activity and containing protein CDecember, 1996Eibl et al.
5582588Ultrasonic therapeutic apparatusDecember, 1996Sakurai et al.
5588432Catheters for imaging, sensing electrical potentials, and ablating tissueDecember, 1996Crowley
5590653Ultrasonic wave medical treatment apparatus suitable for use under guidance of magnetic resonance imagingJanuary, 1997Aida et al.
5593394Shaft for a catheter systemJanuary, 1997Kanesaka et al.
5599326Catheter with multi-layer sectionFebruary, 1997Carter
5603445Ultrasonic wire bonder and transducer improvementsFebruary, 1997Hill et al.228/4.5
5607404Low friction inner lumenMarch, 1997Khairkhahan
5607440Trocar with lockable shieldMarch, 1997Danks et al.
5611807Ultrasonic angioplasty balloon catheterMarch, 1997O'Boyle
5622170Apparatus for determining the position and orientation of an invasive portion of a probe inside a three-dimensional bodyApril, 1997Schulz
5628743Dual mode ultrasonic surgical apparatusMay, 1997Cimino606/1
5630427Medical shaft movement control device and methodMay, 1997Hastings
5630797Everting catheter system and method of utilizing the sameMay, 1997Diedrich et al.
5630837Acoustic ablationMay, 1997Crowley601/2
5647846Catheter having geometrically shaped surface and method of manufactureJuly, 1997Berg et al.
5651364Method and apparatus for intravascularJuly, 1997Yock
5651776Luer-type connectorJuly, 1997Appling et al.
5662620Transport catheterSeptember, 1997Lieber et al.
5666970Locking mechanism for cathetersSeptember, 1997Smith
5669881Vascular introducer system incorporating inflatable occlusion balloonSeptember, 1997Dunshee
5672172Surgical instrument with ultrasound pulse generatorSeptember, 1997Zupkas606/20
5676011Precious metal wire drawing apparatusOctober, 1997Allison
5676649Phacoemulsification cutting tipOctober, 1997Boukhny et al.604/22
5681296Catheter tube and a method of processing the inner surface of a tubeOctober, 1997Ishida
5685312Angioplasty apparatus facilitating rapid exchanges and methodNovember, 1997Yock
5687474Method of assembling and cooling a package structure with accessible chipNovember, 1997Hamzehdoost et al.
5688235Ultrasonic treatment apparatusNovember, 1997Sakurai et al.
5690611Process for the treatment of atrial arrhythima using a catheter guided by shaped giding introducersNovember, 1997Swartz et al.
5693029Pro-cell intra-cavity therapeutic agent delivery deviceDecember, 1997Leonhardt
5704787Hardened ultrasonic dental surgical tips and processJanuary, 1998Hickok et al.
5707359Expanding trocar assemblyJanuary, 1998Bufalini
5709120Straight line drawing deviceJanuary, 1998Shilling
5713363Ultrasound catheter and method for imaging and hemodynamic monitoringFebruary, 1998Seward et al.
5713848Vibrating catheterFebruary, 1998Dubrul et al.604/22
5715825Acoustic imaging catheter and the likeFebruary, 1998Crowley
5720300High performance wires for use in medical devices and alloys thereforFebruary, 1998Fagan et al.
5720710Remedial ultrasonic wave generating apparatusFebruary, 1998Tachibana et al.601/2
5722627Mechanism for adjusting the height of a drum chair or the like chairMarch, 1998Hoshino
5725494Apparatus and methods for ultrasonically enhanced intraluminal therapyMarch, 1998Brisken604/22
5728062Apparatus and methods for vibratory intraluminal therapy employing magnetostrictive transducersMarch, 1998Brisken604/22
5735811Apparatus and methods for ultrasonically enhanced fluid deliveryApril, 1998Brisken604/22
5741225Method for treating the prostateApril, 1998Lax et al.604/22
5749889Method and apparatus for performing biopsyMay, 1998Bacich et al.
5749914Catheter for obstructed stentMay, 1998Janssen
5752932Intravascular catheter with a recoverable guide wire lumen and method of useMay, 1998Ellis et al.
5758420Process of manufacturing an aneurysm clipJune, 1998Schmidt et al.
5765418Method for making an implantable medical device from a refractory metalJune, 1998Rosenberg
5769868Angioplasty apparatus facilitating rapid exchangesJune, 1998Yock
5772627Ultrasonic tissue resector for neurosurgeryJune, 1998Acosta et al.604/22
5775328Device for use in temporary insertion of a sensor within a patient's bodyJuly, 1998Lowe et al.
5776065Apparatus and method for controlling an ultrasound transducer arrayJuly, 1998Mehmanpazir et al.
5782861Percutaneous hemostasis deviceJuly, 1998Cragg et al.
5797920Catheter apparatus and method using a shape-memory alloy cuff for creating a bypass graft in-vivoAugust, 1998Kim
5803083Guiding catheter with ultrasound imaging capabilitySeptember, 1998Buck et al.
5810860Easily fabricated rotary-drive acoustic ablation catheterSeptember, 1998Adrian
5813998Method and system for coupling acoustic energy using an end-fire arraySeptember, 1998Dias
5824042Endoluminal prostheses having position indicating markersOctober, 1998Lombardi et al.
5827203Ultrasound system and method for myocardial revascularizationOctober, 1998Nita601/2
5827229Percutaneous aspiration thrombectomy catheter systemOctober, 1998Auth et al.
5830125Catheter introducer with suture capabilityNovember, 1998Scribner et al.
5830127Method and apparatus for cleaning endoscopes and the likeNovember, 1998DeCastro
5830195Couplings for medical cannulaeNovember, 1998Peters et al.
5833644Method for emboli containmentNovember, 1998Zadno-Azizi et al.
5833650Catheter apparatus and method for treating occluded vesselsNovember, 1998Imran
5836306Exchange accessory for use with a monorail catheterNovember, 1998Duane et al.
5836896Method of inhibiting restenosis by applying ultrasonic energyNovember, 1998Rosenschein601/2
5836897Ultrasonic treatment apparatusNovember, 1998Sakuri et al.601/2
5840027Guiding introducer system for use in the right atriumNovember, 1998Swartz et al.
5840031Catheters for imaging, sensing electrical potentials and ablating tissueNovember, 1998Crowley
5840151Apparatus and dies for forming peelable tube assembliesNovember, 1998Munsch
5843017Multifunctional tissue dissecting instrumentDecember, 1998Yoon604/22
5846218Balloon catheters having ultrasonically driven interface surfaces and methods for their useDecember, 1998Brisken et al.604/22
5849009Flexible probe for high frequency skin treatmentDecember, 1998Bernaz
5861023Thrombus and tissue ingrowth inhibiting overlays for defibrillator shocking coil electrodesJanuary, 1999Vachon
5868773Shielded trocar with safety locking mechanismFebruary, 1999Danks et al.
5868778Vascular sealing apparatus and methodFebruary, 1999Gershony et al.
5875782Methods and devices for minimally invasive coronary artery revascularization on a beating heart without cardiopulmonary bypassMarch, 1999Ferrari et al.
5882347Catheter with internal stiffening ridgesMarch, 1999Mouris-Laan et al.
5890406Electronic torque limiting and parts marking wrenchApril, 1999Thorn
5891149Apparatus for removal of plastics cementApril, 1999Young et al.606/80
5895370Medical probe (with stylets) deviceApril, 1999Edwards et al.604/22
5895997Frequency modulated ultrasonic generatorApril, 1999Puskas et al.
5897557Bone fracture reinforcement structure and methodApril, 1999Chin et al.
5897569Ultrasonic generator with supervisory control circuitryApril, 1999Kellogg et al.
5902289Precurved guiding introducer system for treatment of atrial arrhythmiaMay, 1999Swartz et al.
5904670Catheters and methods for guiding drugs and other agents to an intended site by deployable groovesMay, 1999Schreiner
5906628Ultrasonic treatment instrumentMay, 1999Miyawaki et al.
5908381Directional surgical device for use with endoscope, gastroscope, colonoscope or the likeJune, 1999Aznoian et al.
5910129Catheter distal assembly with pull wiresJune, 1999Koblish et al.
5916192Ultrasonic angioplasty-atherectomy catheter and method of useJune, 1999Nita et al.
5916210Catheter for laser treatment of atherosclerotic plaque and other tissue abnormalitiesJune, 1999Winston
5919163Catheter with slidable balloonJuly, 1999Glickman
5919174Suction valve assemblyJuly, 1999Hanson
5920395System for locating relative positions of objects in three dimensional spaceJuly, 1999Schulz
5921915Directional surgical device for use with endoscope, gastroscope, colonoscope or the likeJuly, 1999Aznoian et al.
5925016Systems and methods for drug delivery including treating thrombosis by driving a drug or lytic agent through the thrombus by pressureJuly, 1999Chornenky et al.
5928218Medical material removal method and associated instrumentationJuly, 1999Gelbfish
5931805Catheters comprising bending transducers and methods for their useAugust, 1999Brisken604/22
5935096Grooved phaco-emulsification needleAugust, 1999Barrett604/22
5935142Cavitation-assisted method of material separationAugust, 1999Hood606/169
5935143Ultrasonic knifeAugust, 1999Hood
5944687Opto-acoustic transducer for medical applicationsAugust, 1999Benett et al.
5951480Ultrasound imaging guidewire with static central core and tipSeptember, 1999White et al.
5951539Optimized high performance multiple coil spiral-wound vascular catheterSeptember, 1999Nita et al.
5951583Thrombin and collagen procoagulant and process for making the sameSeptember, 1999Jensen et al.
5957882Ultrasound devices for ablating and removing obstructive matter from anatomical passageways and blood vesselsSeptember, 1999Nita et al.604/22
5961444In vitro fertilization procedure using direct visionOctober, 1999Thompson
5964756Transurethral needle ablation device with replaceable stylet cartridgeOctober, 1999McGaffigan et al.606/41
5971949Ultrasound transmission apparatus and method of using sameOctober, 1999Levin et al.
5971960Trocar with expandable members for retaining the trocarOctober, 1999Flom et al.
5971983Tissue ablation device and method of useOctober, 1999Lesh
5974884Ultrasonic diagnostic apparatus and ultrasonic probe with acoustic matching layer having continuously varied acoustic impedance in the thickness directionNovember, 1999Sano et al.
5976093Vascular catheter having low-profile distal endNovember, 1999Jang
5980563Ablation apparatus and methods for treating atherosclerosisNovember, 1999Tu et al.
5981444Process for manufacturing a superconducting wire of compound oxide-type ceramicsNovember, 1999Sawada et al.
5984882Methods for prevention and treatment of cancer and other proliferative diseases with ultrasonic energyNovember, 1999Rosenschein et al.
5984950Percutaneous hemostasis deviceNovember, 1999Cragg et al.
5987349Method for determining the position and orientation of two moveable objects in three-dimensional spaceNovember, 1999Schulz
5989208Therapeutic ultrasound systemNovember, 1999Nita604/22
5989209Grooved phaco-emulsification needleNovember, 1999Barrett604/22
5989274Methods and devices for improving blood flow to a heart of a patientNovember, 1999Davison et al.606/169
5989280Stent delivery apparatus and methodNovember, 1999Euteneuer et al.623/1.1
5993408Thin tip phaco needleNovember, 1999Zaleski
5997497Ultrasound catheter having integrated drug delivery system and methods of using sameDecember, 1999Nita et al.604/22
5997523Vascular catheter having low-profile distal endDecember, 1999Jang
6001355Pro-tPA for the treatment of thrombosis, embolism and related conditionsDecember, 1999Dowdle
6004269Catheters for imaging, sensing electrical potentials, and ablating tissueDecember, 1999Crowley et al.
6007514Ultrasound system with pathfinding guidewireDecember, 1999Nita
6010476Apparatus for performing transmyocardial revascularizationJanuary, 2000Saadat
6010498Endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulasJanuary, 2000Guglielmi
6017340Pre-curved wire guided papillotome having a shape memory tip for controlled bending and orientationJanuary, 2000Cassidy et al.
6017354Integrated system for powered surgical toolsJanuary, 2000Culp et al.
6017359Vascular sealing apparatusJanuary, 2000Gershony et al.
6019777Catheter and method for a stent delivery systemFebruary, 2000Mackenzie
6021694Surgical torque wrenchFebruary, 2000Beger
6022336Catheter system for emboli containmentFebruary, 2000Zadno-Azizi et al.
6022369Wire device with detachable endFebruary, 2000Jacobsen et al.
6024718Intraluminal directed ultrasound delivery deviceFebruary, 2000Chen et al.604/22
6027515Pulsed ultrasonic device and methodFebruary, 2000Cimino
6032078Voltage controlled variable tuning antennaFebruary, 2000Rudie607/101
6033375Ultrasonic probe with isolated and teflon coated outer cannulaMarch, 2000Brumbach604/22
6033411Precision depth guided instruments for use in vertebroplastyMarch, 2000Preissman
6036648Machine tilt transducer and methods of makingMarch, 2000White et al.600/459
6036671Breakaway syringe and disposal apparatusMarch, 2000Frey
6036697Balloon catheter with balloon inflation at distal end of balloonMarch, 2000DiCaprio
6036715Angioplasty apparatus facilitating rapid exchangesMarch, 2000Yock
6039693Volumetric image ultrasound transducer underfluid catheter systemMarch, 2000Seward et al.
6039762Reinforced bone graft substitutesMarch, 2000McKay
6045527Detection of ophthalmic surgical handpiece using shorting barApril, 2000Appelbaum et al.
6048329Catheter distal assembly with pull wiresApril, 2000Thompson et al.
6050949Catheher system having connectable distal and proximal portionsApril, 2000White et al.
6051772Method and apparatus for emulating a frequency modulation deviceApril, 2000Cameron et al.
6053904Thin wall catheter introducer systemApril, 2000Scribner et al.
RE36693Container and method for transporting a syringe containing radioactive materialMay, 2000Reich
6056722Delivery mechanism for balloons, drugs, stents and other physical/mechanical agents and methods of useMay, 2000Jayaraman
6057798Apparatus and method for frequency modulationMay, 2000Burrier et al.
6059789Drill guide for creating a tunnel in bone for fixating soft tissue to the bone and kit and method for fixating soft tissue to boneMay, 2000Dinger et al.
6062001Sharps disposal containerMay, 2000Kunik
6062059Manufacture of extrusion diesMay, 2000Feldcamp
6068610Intravascular catheter with a recoverable guide wire lumen and method of useMay, 2000Ellis et al.
6077285Torsional ultrasound handpieceJune, 2000Boukhny606/169
6083191Ultrasonic surgical apparatusJuly, 2000Rose
6083501Drug for prevention and therapy of diseases caused by fibrinoid formation or thrombus formation in the lung and model animals of the diseasesJuly, 2000Miyata et al.
6090118Rotational thrombectomy apparatus and method with standing waveJuly, 2000McGuckin, Jr.
6099464Bending sheath for probeAugust, 2000Shimizu et al.
6106475Device for use in temporary insertion of a sensor within a patient's bodyAugust, 2000Lowe et al.
6106538Method for forming an internal coronary bypassAugust, 2000Shiber
6107161Semiconductor chip and a method for manufacturing thereofAugust, 2000Kitaguro et al.
6110142Balloons for medical devices and fabrication thereofAugust, 2000Pinchuk et al.
6110176Methods for extracting bone marrowAugust, 2000Shapira
6113558Pulsed mode lysis methodSeptember, 2000Rosenschein et al.
6113570Method of removing thrombosis in fistulaeSeptember, 2000Siegel et al.
6113580Cervical barrier shield for female vaginal doucheSeptember, 2000Dolisi
6123718Balloon catheterSeptember, 2000Tu et al.
6124150Transverse hybrid LOC packageSeptember, 2000Corisis
6124546Integrated circuit chip package and method of making the sameSeptember, 2000Hayward et al.
6124634Micromachined chip scale packageSeptember, 2000Akram et al.
6129672Volumetric image ultrasound transducer underfluid catheter systemOctober, 2000Seward et al.
6146380Bent tip electrical surgical probeNovember, 2000Racz et al.
6146381Catheter having distal region for deflecting axial forcesNovember, 2000Bowe et al.
6156018Guiding introducer system for use in medical procedures in the left ventricleDecember, 2000Hassett
6159195Exchange catheter and method of useDecember, 2000Ha et al.
6162053Analog dental wrenchDecember, 2000Hollander
6165197Angioplasty apparatus facilitating rapid exchangesDecember, 2000Yock
6190353Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular proceduresFebruary, 2001Makower et al.
6193683Closed loop temperature controlled phacoemulsification system to prevent corneal burnsFebruary, 2001Ludin et al.
6200269Forward-scanning ultrasound catheter probeMarch, 2001Lin et al.
6200315Left atrium ablation catheterMarch, 2001Gaiser et al.
6203516Phacoemulsification device and method for using dual loop frequency and power controlMarch, 2001Kepley
6203568Endoluminal prostheses having position indicating markersMarch, 2001Lombardi et al.
6224565Protective sheath and method for ultrasonic probesMay, 2001Cimino604/22
6228046Catheters comprising a plurality of oscillators and methods for their useMay, 2001Brisken604/22
6231514Device for use in temporary insertion of a sensor within a patient's bodyMay, 2001Lowe et al.
6231518Intrapericardial electrophysiological proceduresMay, 2001Grabek et al.
6234971Vascular catheter having low-profile distal endMay, 2001Jang
6235000Apparatus for crossing total occlusion in blood vesselsMay, 2001Milo et al.
6241703Ultrasound transmission apparatus having a tipJune, 2001Levin et al.
6245095Method and apparatus for location and temperature specific drug action such as thrombolysisJune, 2001Dobak, III et al.
6247592System for disposal of contaminated medical productsJune, 2001Racicot et al.
6258798Method for treatment of unstable coronary artery disease by an early revascularisation together with administration of a low molecular weight heparinJuly, 2001Wallentin
6262062Method of treating the syndrome of coronary heart disease risk factors in humansJuly, 2001Clemens
6270460Apparatus and method to limit the life span of a diagnostic medical ultrasound probeAugust, 2001McCartan et al.
6277084Ultrasonic medical deviceAugust, 2001Abele et al.
6279743Device for facilitating engagement and disengagement between needles and associated syringes and sheaths and for receiving sharpsAugust, 2001Ballard et al.
6280413Thrombolytic filtration and drug delivery catheter with a self-expanding portionAugust, 2001Clark et al.
6283951Systems and methods for delivering drugs to selected locations within the bodySeptember, 2001Flaherty et al.
6287271Motion catheterSeptember, 2001Dubrul et al.604/22
6287272Balloon catheters having ultrasonically driven interface surfaces and methods for their useSeptember, 2001Brisken et al.
6290662Portable, self-contained apparatus for deep vein thrombosis (DVT) prophylaxisSeptember, 2001Morris et al.
6290673Expandable medical device delivery system and methodSeptember, 2001Shanley
6293725Collet and methodSeptember, 2001Winkvist
6296658Vascular sealing apparatusOctober, 2001Gershony et al.
6303635Thrombolytic drugOctober, 2001Kawai et al.
6306097Ultrasound imaging catheter guiding assembly with catheter working portOctober, 2001Park et al.
6307156High flexibility and heat dissipating coaxial cableOctober, 2001Avellanet
6309379Sheath for selective delivery of multiple intravascular devices and methods of use thereofOctober, 2001Willard et al.
6312406Delivery mechanism for balloons, drugs, stents and other physical/mechanical agents and method of useNovember, 2001Jayaraman
6322541Vascular introducer sheath and hemostasis valve for use therewithNovember, 2001West et al.
6329778Integrated system for powered surgical toolsDecember, 2001Culp et al.
6346091Detachable coil for aneurysm therapyFebruary, 2002Jacobsen et al.
6348039Rectal temperature sensing probeFebruary, 2002Flachman et al.
6358252Apparatus for extracting bone marrowMarch, 2002Shapira
6364840Acoustic imaging catheter and the likeApril, 2002Crowley600/463
6364841System and method for intraluminal imagingApril, 2002White et al.
6368611Anti-infective covering for percutaneous and vascular access device and coating methodApril, 2002Whitbourne et al.
6376513Drug for relieving pain and promoting the removal of calculi in urolithiasisApril, 2002Akahane et al.
6383151Circumferential ablation device assemblyMay, 2002Diederich et al.
6391042Pulsed ultrasonic device and methodMay, 2002Cimino
6396293Self-closing spring probeMay, 2002Vinther et al.
6398776Tubular medical deviceJune, 2002Sekino et al.
6398792Angioplasty catheter with transducer using balloon for focusing of ultrasonic energy and method for useJune, 2002O'Connor
6410560Drug for relieving pain and promoting the removal of calculi in urolithiasisJune, 2002Akahane et al.
6416511Circumferential ablation device assemblyJuly, 2002Lesh et al.
6416530Device and method for selectively removing a thrombus filterJuly, 2002DeVries et al.
6416737Increasing bone strength with selected bisphosphonatesJuly, 2002Manolagas et al.
6419644System and method for intraluminal imagingJuly, 2002White et al.
6433464Apparatus for selectively dissolving and removing material using ultra-high frequency ultrasoundAugust, 2002Jones
6440726Expression vectors comprising multiple shear stress responsive elements (SSRE) and methods of use for treating disorders related to vasculogenesis and/or angiogenesis in a shear stress environmentAugust, 2002Resnick
6440947Method for treating occlusive peripheral vascular disease and coronary diseaseAugust, 2002Barron et al.
6443903System and method for intraluminal imagingSeptember, 2002White et al.
6450975Ultrasonic transmission guide wireSeptember, 2002Brennan et al.
6451303Method of treating coronary artery disease by administering a recombinant FGFSeptember, 2002Whitehouse et al.
6454737Ultrasonic angioplasty-atherectomy catheter and method of useSeptember, 2002Nita et al.
6454757Ultrasonic method for ablating and removing obstructive matter from anatomical passageways and blood vesselsSeptember, 2002Nita et al.
6457365Method and apparatus for ultrasonic imagingOctober, 2002Stephens et al.
6458375Malleable paste with allograft bone reinforcement for filling bone defectsOctober, 2002Gertzman et al.
6462172Purification of tissue plasminogen activator (TPA)October, 2002Maclennan et al.
6464660Balloon catheters having ultrasonically driven interface surfaces and methods for their useOctober, 2002Brisken et al.
6469419Ultrasonic motor capable of sensing both longitudinal and torsional vibrations thereof and method for operating the sameOctober, 2002Kato et al.
6471656Method and system for pressure based measurements of CFR and additional clinical hemodynamic parametersOctober, 2002Shalman et al.
6475185Occlusion deviceNovember, 2002Rauker et al.
6478751Bone marrow aspiration needleNovember, 2002Krueger et al.
6482218Wire-shaped ultrasonic catheter with diamond coated head for ultrasonic angioplastyNovember, 2002Tran
6485481Catheter systemNovember, 2002Pfeiffer
6491710Balloon catheter for pulmonary vein isolationDecember, 2002Satake
6491711Balloon catheter with non-circular balloon taper and method of useDecember, 2002Durcan
6494883Bone reinforcersDecember, 2002Ferree
6494885Endoscopic stone extraction device with rotatable basketDecember, 2002Dhindsa
6494891Ultrasonic angioplasty transmission memberDecember, 2002Cornish et al.
6494893Trocar system having expandable portDecember, 2002Dubrul et al.
6497667Ultrasonic probe using ribbon cable attachment systemDecember, 2002Miller et al.
6497698Method and apparatus for treating a patientDecember, 2002Fonger et al.
6503223Balloon catheterJanuary, 2003Sekido et al.
6508781Ultrasonic ablation catheter transmission wire connector assemblyJanuary, 2003Brennan et al.
6508782Thrombolysis deviceJanuary, 2003Evans et al.
6509348Combination of an ADP-receptor blocking antiplatelet drug and a thromboxane A2 receptor antagonist and a method for inhibiting thrombus formation employing such combinationJanuary, 2003Ogletree
6511492Embolectomy catheters and methods for treating stroke and other small vessel thromboembolic disordersJanuary, 2003Rosenbluth et al.
6512957Catheter having a guide sleeve for displacing a pre-bent guidewireJanuary, 2003Witte
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Primary Examiner:
Winakur, Eric F.
Assistant Examiner:
Cheng, Jacqueline
Attorney, Agent or Firm:
Fish & Richardson P.C.
Claims:
We claim:

1. An ultrasonic medical device for tissue ablation comprising: an elongated probe having a proximal end, a distal end and at least two regions of differing cross sectional dimension, wherein a length of the elongated probe is configured to oscillate in a direction transverse to a longitudinal axis of the elongated probe to emit transverse ultrasonic energy along the length of the elongated probe so that a plurality of transverse nodes and transverse anti-nodes are formed along the length of the elongated probe; and a sheath assembly at least partially surrounding the elongated probe, the sheath assembly comprising at least one sheath defining a fenestration between a proximal and distal end of the at least one sheath, the at least one sheath being configured to substantially dampen ultrasonic energy such that ultrasonic energy delivered by the elongated probe is focused toward a region adjacent the fenestration.

2. The device of claim 1, wherein the sheath assembly covers at least a portion of the elongated probe, the sheath assembly comprising a longitudinally extending structural wall that defines a longitudinally extending hollow interior for accommodating at least a portion of the elongated probe, wherein the longitudinally extending structural wall of the sheath assembly is substantially self supporting so that the longitudinally extending structural wall substantially maintains a same shape with the elongated probe disposed in the longitudinally extending hollow interior as without the elongated probe disposed in the longitudinally extending hollow interior.

3. The device of claim 1, wherein the sheath assembly is constructed to substantially prevent a transmission of cavitational energy generated by the elongated probe to a surrounding environment.

4. The device of claim 1, wherein the sheath assembly further comprises one or more devices capable of manipulating a tissue.

5. The device of claim 1, wherein the sheath assembly further comprises at least one reflective element configured to reflect ultrasonic energy.

6. The device of claim 1, wherein the sheath assembly further comprises at least one irrigation channel.

7. The device of claim 1, wherein the sheath assembly further comprises at least one aspiration channel.

8. The device of claim 1, wherein the sheath assembly further comprises at least one channel for delivering a therapeutic agent therethrough.

9. The device of claim 1, wherein the sheath assembly is adapted for use with an imaging system.

10. A method of modulating, focusing and directing a cavitational energy emitted from an ultrasonic probe vibrating in a direction transverse to a longitudinal axis of the ultrasonic probe for tissue ablation comprising: enclosing at least a portion of the ultrasonic probe within a sheath assembly comprising a sheath defining at least one fenestration between a proximal end and a distal end of the sheath; inserting the ultrasonic probe into a blood vessel; guiding the ultrasonic probe and the sheath assembly into the blood vessel and to a site of an occlusion; positioning the ultrasonic probe and the sheath assembly such that the at least one fenestration is in proximity with the occlusion; providing an ultrasonic excitation signal to the ultrasonic medical device and transferring the ultrasonic excitation signal along a length of the ultrasonic probe to a flexible probe tip, thereby causing a transverse vibration of the length of the ultrasonic probe and the flexible probe tip and a generation of a plurality of transverse nodes and anti-nodes of the cavitational energy along the length of the ultrasonic probe and the flexible probe tip; and controlling a selective transmission of cavitational energy through the at least one fenestration in the sheath, thereby directing the cavitational energy in an area of the occlusion within the blood vessel to cause fragmentation of the occlusion.

11. The method of claim 10, wherein the sheath assembly is capable of partially shielding tissue at a site of a surgical procedure from the ultrasonic probe.

12. The method of claim 10, further comprising removing at least one fragment of the occlusion through an aspiration conduit of the sheath assembly.

13. The method of claim 10, further comprising supplying an irrigating fluid to the site of the occlusion through an irrigation conduit of the sheath assembly.

14. The method of claim 10, further comprising delivering a therapeutic agent through a conduit of the sheath assembly.

15. The method of claim 10, further comprising positioning the ultrasonic probe proximal to the occlusion using an imaging system.

16. The method of claim 10, comprising manipulating tissue with a tissue manipulation device of the sheath assembly.

17. The method of claim 10, further comprising shielding an ultrasound energy emitted from the ultrasonic probe with the sheath assembly, and visualizing a surgical site with an ultrasound imaging system, the shielding of the ultrasound energy increasing the resolution of the surgical site visualized by the ultrasound imaging system.

18. The method of claim 10, further comprising introducing the sheath assembly from an exterior of a patient to the site of the occlusion, and introducing the ultrasonic probe into the sheath assembly and guiding the ultrasonic probe to a surgical site.

19. A medical device, comprising: an ultrasonic probe configured to emit ultrasonic energy transversely along a portion of the ultrasonic probe; and a sheath comprising a proximal end and a distal end, the sheath at least partially surrounding the ultrasonic probe and defining a fenestration between the proximal and distal ends of the sheath, the sheath being configured to substantially dampen ultrasonic energy such that ultrasonic energy delivered by the medical device is focused toward a region adjacent the fenestration.

20. The medical device of claim 19, wherein the sheath defines a plurality of fenestrations between the proximal and distal ends of the sheath.

21. The medical device of claim 19, wherein the fenestration extends from a proximal end of the sheath to a distal end of the sheath.

22. The medical device of claim 19, further comprising at least one reflective element disposed on an interior surface of the sheath.

23. The medical device of claim 19, wherein the sheath is at least partially surrounded by a second, retractable sheath.

24. The medical device of claim 19, wherein the sheath is constructed to substantially prevent ultrasonic energy from passing therethrough.

25. The medical device of claim 24, wherein the sheath comprises one or more materials that are capable of dissipating ultrasonic energy.

Description:

FIELD OF THE INVENTION

The present invention relates generally to a shielded ultrasonic medical probe operating in a transverse mode for ablating and removing undesired tissue. In particular, the invention provides one or more acoustical sheaths for use with the probe, allowing the user to control and focus the energy emitted by the probe in a manner most suited to the desired medical procedure.

BACKGROUND OF THE INVENTION

Ultrasonic energy has been considered for tissue ablation and fragmentation of plaque and thrombosis for removal of intravascular occlusions due to atherosclerotic plaque and intravascular blood clots. Surgical devices utilizing ultrasonic probes for generation and transmission of ultrasonic energy, have been disclosed in the art (U.S. Pat. Nos. 5,112,300; 5,180,363; 4,989,583; 4,931,047; 4,922,902; and 3,805,787). Typically, the energy produced by an ultrasonic probe is in the form of very intense, high frequency sound vibrations, results in fragmentation of tissue (plaque and thrombosis) either as a result of mechanical action thereon or “cavitation” thereof, in which high energy ultrasound frequency applied to liquids generates vapor-filled microbubbles or “cavities” with the concomitant rapid expansion and collapse of the cavities that is accompanied by intense localized hydraulic shock, that causes fragmentation or dissolution of the tissue. Medical applications for ultrasonic probes providing cavitation include surgical procedures for ablation of tissues, for example, treatment of cancer, tissue remodeling, liposuction, and removal of vascular occlusions. Typically, ultrasonic probes described in the art for use in surgical procedures include a mechanism for irrigating an area where the ultrasonic treatment is being performed (e.g., a body cavity or lumen) to wash tissue debris from the area, and may further include an aspiration means to remove irrigation fluid and tissue debris from the site of the procedure. Mechanisms used for irrigation or aspiration described in the art are generally structured such that they increase the overall cross-sectional profile of the probe, by including inner and outer concentric lumens proximal to or within the probe to provide irrigation and aspiration channels. In addition to making the probe more invasive, prior art probes may also maintain a strict orientation of the aspiration and the irrigation mechanism, such that the inner and outer lumens for irrigation and aspiration remain in a fixed position relative to one another, which is generally closely adjacent the area of treatment. Thus, the irrigation lumen would not extend beyond the suction lumen (i.e., there is no movement of the lumens relative to one another) and any aspiration would be limited to picking up fluid and/or tissue remnants within the defined distance between the two lumens.

Ultrasonic probes described in the art for tissue ablation suffer from a number of limitations. Such probes depend on longitudinal vibration of the ultrasonic member comprising the probe i.e. vibration of the probe in the direction of the longitudinal probe axis to effect tissue fragmentation. Probe action in this modality therefore depends primarily on mechanical and thermal action of the probe tip for disrupting tissue, since the cavitational energy emanating from the tip, especially in narrow diameter probes such as those used to remove vascular occlusions, is minimal due to the small surface area of the tip itself. This primary mode of action imposes the following limitations on probe efficiency:

i) tissue ablation is restricted to very small area defined by the surface area of the probe tip, thereby necessitating time consuming surgical procedures to remove relatively large occluded areas with blood vessels in comparison to instruments which excise tissue by mechanical cutting, electrocautery, or cryoexcision methods.

ii) occurrence of late restenosis (typically within three months), and to a lesser extent acute re-occlusion after coronary angioplasty are major clinical problems limiting the long-term efficacy of ultrasonic surgical procedures for treatment of atherosclerosis and coronary angioplasty. While the pathogenosis of restenosis is still unclear, it has been demonstrated from autopsy specimens from patients with restenosis the pathophysiologic process leading to acute occlusion after coronary angioplasty is related either to a thrombotic mechanism or to major plaque dissection and superimposed thrombosis, and that these events leading to chronic restenosis involves vascular injury, platelet deposition and thrombosis and connective tissue synthesis. Such post operative processes are typically result from localized trauma at the surgical site caused by mechanical and thermal action of longitudinally vibrating probes.

Attempts to reduce some of the aforementioned problems associated with longitudinally vibrating probes have been disclosed in the art, wherein the primary action of the probe through longitudinal vibration is supplemented by a limited, supplementary transverse vibration of the probe tip i.e. perpendicular to the longitudinal axis of the probe. It is proposed that such secondary transverse vibrations in these probes will result in increased efficiency for surgical procedures. For example, U.S. Pat. No. 4,961,424 to Kubota, et al. discloses an ultrasonic treatment device that produces both a longitudinal and transverse motion at the tip of the probe. The Kubota, et al. device, however, still relies solely on the tip of the probe to act as a working surface. Thus, while destruction of tissue in proximity to the tip of the probe is more efficient, tissue destruction is still predominantly limited to the area in the immediate vicinity at the tip of the probe. U.S. Pat. No. 4,504,264 to Kelman discloses an ultrasonic treatment device, which improves the speed of ultrasonic tissue removal by oscillating the tip of the probe in addition to relying on longitudinal vibrations. Although tissue destruction at the tip of the device is more efficient, the tissue destroying effect of the probe is still limited to the tip of the probe. Both probes described in Kubota, et al., and Kelman, et al., are further limited in that the energy produced at the tip of the probe is unfocused, the action of the probe tends to push the tissue debris ahead of the probe tip. Likewise, the concentration of energy solely at the probe tip results in heating of the probe tip, which can create tissue necrosis, thereby complicating the surgical procedure and potentially compromising the recovery of the patient. Furthermore, such probes do not eliminate the problems associated with longitudinally vibrating probes.

The aforementioned limitations associated with longitudinally vibrating probes can be overcome entirely by utilizing an ultrasonic probe that vibrates exclusively in the transverse mode. Such probes are capable of generating substantially higher cavitational energy through a plurality of anti-nodes along the entire longitudinal axis of the vibrating probe, thereby eliminating the need for mechanical and thermal action at the probe tip. The advancing probe tip can therefore be shielded to prevent mechanical injury to the walls of the blood vessel for example, thereby precluding scarring, platelet deposition and clotting that lead to restenosis. Additionally, such probes are capable of tissue fragmentation over greater surface area (along the entire longitudinal axis) resulting in high efficiency, thus allowing for rapid surgical procedures and substantially eliminating thermal effects on tissue caused by prolonged probe operation.

Since probe vibrating exclusively in a transverse mode is entirely dependent on cavitational energy for their action, important factors for maintaining efficiency of such probes are (i) narrow probe diameter to facilitate oscillation at lower ultrasonic energies and (ii) increased longitudinal axis (probe length) that results in more cavitation anti-nodes. Although narrow probe diameters are advantages especially for negotiation through narrow blood vessels and occluded arteries, the utilization of such probes have been precluded by inability to effectively control the vibrational amplitude of thin probes, that result in potential damage to the probe and greater risk, of tissue damage resulting from their use. The use of narrow diameter probes have been disclosed in the art for providing greater maneuverability ease of insertion in narrow blood vessels. U.S. Pat. No. 4,920,954 to Allinger discloses a narrow diameter ultrasonic device wherein a rigid sleeve is used to prevent transverse vibrations U.S. Pat. No. 5,380,274 discloses a narrow diameter probe for improved longitudinal vibration having a sheath to inhibit transverse vibration U.S. Pat. No. 5,469,853 to Law discloses a thin, longitudinally vibrating ultrasonic device with a bendable sheath that facilitates directing the probe within narrow blood vessels. While the prior art has focused on the need for using sheaths on thin ultrasonic devices, their use has been entirely to prevent transverse, vibrations of the device and to protect such devices from damage resulting from such vibrations

Based on the aforementioned limitations of ultrasonic probes in the art, there is a need for ultrasonic probe functioning in a transverse mode that further obviates the shortcomings of that further overcomes limitations imposed by of narrow diameter requirements for efficient operation of such probes for rapid tissue ablation. Transversely vibrating ultrasonic probes for tissue ablation are described in the Applicant's co-pending provisional applications U.S. Ser. Nos. 60/178,901 and 60/225,060, and 09/776,015 which further describe the design parameters for such a probe its use in ultrasonic devices for tissue ablation. The entirety of these applications are herein incorporated by reference.

There is a further need for controlling the for procedures which require precise delivery of cavitation energy to defined locations, to be able to restrict the cavitation energy emanating circumferentially from a transversely vibrating p at multiple anti-nodes wastes a portion of the energy given off by the probe, as the energy is unfocused and dispensed along the length of the probe.

There is also a need in the art for a means of focussing the cavitational energy emitted by such a probe to deliver the energy to exactly to the desired location within a blood vessel while shielding the surrounding tissue from damage.

SUMMARY OF THE INVENTION

The present invention is directed towards a transversely vibrating ultrasonic probe for tissue ablating surgical devices that overcomes the aforementioned limitations of ultrasonic probes in the art used for this application. Particularly, the present invention is directed towards providing a means to control, direct and focus the cavitation energy from a transversely vibrating ultrasonic probe by utilizing a sheath assembly extending circumferentially along the longitudinal axis of the probe. In accordance with the present invention, there is provided an ultrasonic probe operating in a transverse mode whereby the probe is cable of vibrating in a direction perpendicular to its longitudinal axis upon application of an ultrasonic frequency, capable of precisely focussing or directing the cavitation energy of the probe to defined regions within a blood vessel. The object of this invention can be accomplished by a transversely vibrating ultrasonic probe described in a co-application submitted by the applicants (###) the entirety of which is herein incorporated by reference.

Further in accordance with the invention, a sheath, a sleeve or other damping member provided with fenestrations is a sheath that is adapted circumferentially along the probe axis, thereby providing control over release of cavitation energy in specific regions along the probe axis. Non-fenestrated areas of the said sheath or sleeve effectively block cavitation energy emanating from the probe from such areas.

Still further in accordance with the invention, a sheath assembly comprising one or more sheaths may can be adapted to the ultrasonic probe, thereby providing a means of containing, focussing, and transmitting energy generated along the length of the probe to one or more defined locations. The sheaths of the present invention also provide the user with a means of protecting regions of tissue from physical contact with the probe. In one embodiment of the invention he sheaths also comprise a means for aspiration and irrigation of the region of probe activity, as well as a means of introducing a drug or compound to the site of probe activity.

In one aspect, a plurality of sheaths are used in combination to provide another level of precision control over the direction of cavitation energy to a tissue in the vicinity of the probe. In one embodiment of the invention, the sheath encloses a means of introducing fluid into the site of the procedure, and a means for aspirating fluid and tissue debris from the site of the procedure. In another aspect the sheath assembly further encloses a means of introducing a drug intravascularly that dissolves clots and prevents the recurrence of stenosis. The ultrasonic oscillation of the probe of the present invention will be used to facilitate the penetration of antithrombogenic agents into the vascular or luminal walls to inhibit restenosis. Preferred antithrombogenic agents include heparin, hirudin, hirulog, urokinase, streptokinase, tPA, and similar agents. In a further embodiment, the probe tip can be moved within the sheath. In yet another aspect, the irrigation and aspiration means, and the probe tip, can all be manipulated and repositioned relative to one another within the sheath. In another embodiment, the sheath is shaped in such a way that it may capture or grasp sections of tissue that can be ablated with the probe.

Still further in accordance with the invention, the sheath provides a guide for the probe tip, protecting tissues from accidental puncture by the sharp, narrow-diameter tip, or from destruction by energy emitted radially from the probe during introduction of the probe to the site. The sheath may be applied either to the probe tip prior to insertion of the probe into the patient, or pre-inserted into the patient prior to the insertion of the probe. The sheath of the present invention can be used to fix the location of one or more shapes relative to the nodes or anti-nodes of a probe acting in transverse action. The location of the reflective shapes can amplify the acoustical wave thereby magnifying the energy. This allows for the use of very small diameter probes which themselves would not have the requisite structural integrity to apply and translate acoustical energy into sufficient mechanical energy to enable ablation of tissues. The reflective shapes can also focus or redirect the energy, effectively converting a transverse probe emitting cavitation energy along its length, to a directed, side fire ultrasonic device.

In a still further aspect of the invention the probe emits transverse ultrasonic energy along its longitudinal axis that may be used to, for example, fragment abnormal cells on the surface of the body cavity which come within the sweep of the probe, or to clear obstructions and constrictions within vasculature or tissue lumen. The device is designed to have a small cross-sectional profile, which also allows the probe to flex along its length, thereby allowing it to be used in a minimally invasive manner. In one aspect, the probe be at least partially contained within the sheath to contain, focus, intensify, and direct the emitted cavitation energy to specific target tissue sites. In another embodiment of the invention, a plurality of sheaths are used in combination to provide another level of precision control over the direction of cavitation energy to a tissue in the vicinity of the probe.

Still further in accordance with the invention, the sheath encloses a means of introducing fluid into the site of the procedure, and a means for aspirating fluid and tissue debris from the site of the procedure. In a further embodiment, the probe tip can be moved within the sheath. In one aspect, the irrigation and aspiration means, and the probe tip, can all be manipulated and repositioned relative to one another within the sheath. In another aspect, the sheath is shaped in such a way that it may capture or grasp sections of tissue that may be ablated with the probe. In yet another embodiment, the sheath provides a guide for the probe tip, protecting tissues from accidental puncture by the sharp, narrow diameter tip, or from destruction by energy emitted radially from the probe. The sheath may be applied to the probe tip prior to insertion of the probe into the patient, or the sheath can be inserted into the patient prior to the insertion of the probe.

The sheath of the present invention can be used to fix the location of one or more shapes relative to the energy nodes or anti-nodes emitted by a transversely vibrating probe. The location of and the particular shape can modulate the energy emitted from the probe at one site, and communicate it to a distant site, for example, it may amplify the acoustical wave at one or more energetic anti-nodes, thereby increasing the energy emitted at the sheath's aperture. This allows for the use of very small diameter probes which themselves would not have the requisite structural integrity to apply and translate acoustical energy into sufficient mechanical energy to enable ablation of tissues. The reflective shapes can also focus or redirect the energy, effectively converting a transverse probe emitting cavitation energy along its length, to for example, a directed, “side-fire” ultrasonic device.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the same parts throughout the different views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the invention.

FIG. 1 illustrates an exemplary ultrasonic device comprising the ultrasonic probe tip constructed in accordance with the principles of the present invention

FIG. 2 shows the areas of maximum vibrations (anti-nodes) and minimum vibrations (nodes) caused by transverse, vibration of probe and probe tip.

FIGS. 3 a - g show different configurations of sheaths comprising the sheath assembly adapted to the probe.

FIG. 4 shows a probe that is substantially contained within a sheath comprising a plurality of fenestrations.

FIG. 5 shows a probe that is substantially contained within a sheath assembly comprising a plurality of adjustable sheaths.

FIG. 6 shows a longitudinal cross-sectional view of the distal end of the probe comprising a central irrigation passage, lateral irrigation lumens and external aspiration channels.

FIG. 7 shows a transverse cross-sectional view of a portion of the probe illustrating the irrigation and aspiration channels.

FIG. 8 are longitudinal cross-sectional views of the distal end of the probe contained within sheaths incorporating angled reflective elements.

FIG. 9 are longitudinal cross-sectional views of the distal end of the probe contained within sheaths incorporating arctuate of reflective elements

DETAILED DESCRIPTION OF INVENTION

The following terms and definitions are used herein:

“Anti-node” as used herein refers to a region of maximum energy emitted by an ultrasonic probe on or proximal to a position along the probe.

“Cavitation” as used herein refers to shock waves produced by ultrasonic vibration, wherein the vibration creates a plurality of microscopic bubbles which rapidly collapse, resulting in molecular collision by water molecules which collide with force, thereby producing the shock waves.

“Cross-sectional diameter” as used herein refers to the diameter of the cylindrical regions of the probe, including the probe tip.

“Fenestration” as used herein refers to an aperture, window, opening, hole, or space.

“Node” as used herein refers to a region of minimum energy emitted by an ultrasonic probe on or proximal to a position along the probe.

“Probe” as used herein refers to a device capable of being adapted to an ultrasonic generator means, which is capable of propagating the energy emitted by the ultrasonic generator means along its length, and is capable of acoustic impedance causing transformation of ultrasonic energy into mechanical energy.

“Sheath” as used herein refers to an apparatus for covering, encasing, or shielding in whole or in part, a probe or portion thereof connected to an ultrasonic generation means.

“Transverse” as used herein refers to vibration of a probe at right angles to the axis of a probe. A “transverse wave” as used herein is a wave propagated along an ultrasonic probe in which the direction of the disturbance at each point of the medium is perpendicular to the wave vector.

“Tuning” as used herein refers to a process of adjusting the frequency of the ultrasonic generator means to select a frequency that establishes a standing wave along the length of the probe.

The present invention provides an ultrasonic medical device for tissue ablation. More particularly the present invention provides an ultrasonic device comprising a probe capable of vibrating ultrasonically in a transverse mode causing generation of cavitational energy circumferentially around the said probe, comprising a protective sheath assembly adapted over the probe that is capable of focussing, directing and modulating the cavitational energy emitted by the probe. The sheath assembly of the invention allows the user to optimize the tissue ablation efficiency of the probe to suit a particular medical procedure.

The probe of the invention is capable of removing tissue at sites wherein the probe makes actual contact with the tissue, and typically in a region that is radially disposed (approximately 2 mm) from the probe, that corresponds to the region of maximum cavitational energy or “anti-nodes” emanating perpendicular to the longitudinal axis of the probe. By eliminating the axial motion of the probe and allowing transverse vibrations only, fragmentation of large areas of tissue spanning the entire length of the probe due to generation of multiple cavitational anti-nodes along the probe length perpendicular to the probe axis. Since substantially larger affected areas within an occluded blood vessel can be denuded of the occluded tissue in a short time, actual treatment time using the transverse mode ultrasonic medical device according to the invention is greatly reduced as compared to methods using pilot art probes that primarily utilize longitudinal vibration (along probe axis) for tissue ablation. Because the thinnest region of the probe is capable of providing, multiple energy anti-nodes along its length, it is desirable to have a means of modulating this energy, thereby providing a precise way of delivering the energy selectively to desired locations, such as for example an occluded region within a blood vessel, while protecting nearby tissues both from the fragmenting energy and physical damage (for example, punctures) from the narrow diameter probe tip. The probe equipped with a sheath assembly such as that described herein, provides a means for modulating the intensity and direction of energy emitted from such a probe. Additionally, the probe equipped with the sheath assembly of the invention provides a more efficient, selective means of delivering energy from the probe to a specific tissue space, or tissue space, for example at the site of an occlusion within a blood vessel, causing rapid fragmentation and ablation of said tissue without detrimental effect other areas within the vessel.

Probes of the present invention are described in the Applicant's co-pending provisional applications U.S. Ser. Nos. 60/178,901 and 60/225,060 which further describe the design parameters for an ultrasonic probe operating in a transverse mode and the use of such a probe to remodel tissues. The entirety of these applications are herein incorporated by reference.

The present invention allows the selective application of cavitation energy emitted from an ultrasonic probe to tissue. The probe is adapted to an ultrasonic generator means that selectably provides energy over a frequency range of from about 20 kHz to about 80 kHz. In the currently preferred embodiment, the frequency of ultrasonic energy is from 20,000 Hertz to 35,000 Hertz. Frequencies in this range are specifically destructive of hydrated (water-laden) tissues, while substantially ineffective toward high-collagen connective tissue, or other fibrous tissues such as skin or muscle tissues. The amount of cavitation energy to be applied to a particular site requiring treatment is a function of the amplitude and frequency of vibration of the probe, as well as the longitudinal length of the probe tip, the proximity of the tip to a tissue, and the degree to which the probe tip is exposed to the tissues. Control over this last variable can be effectuated through the sheath of the present invention.

A significant advantage of the ultrasonic medical device of the invention is that it physically destroys and removes undesired tissue through the mechanism of cavitation, which is non-thermal. As a consequence, the complications which are arise from thermal destruction or necrosis of tissue are not observed. The increase in local temperature is most likely a result of the heating of the probe. By using the probe contained within a sheath of the present invention the probe is substantially contained and isolated from direct contact with the tissues, thereby enabling destruction of tissues with only a small increase in local temperature, about 7° C. from normal body temperature. The use of a sheath further diminishes or prevents the local temperature rise. Accordingly, In one embodiment, the sheath of the present invention provides a means of insulating surrounding tissue from the thermal side effects of the ultrasonic probe.

The length and diameter of the sheath used in a particular surgical procedure is dependent on the type of probe used, the degree to which the probe length will be inserted into the patient, and the degree of shielding that is required based on the specific areas to be treated. For example, in an application whereby prostate tissue is removed via an intra-urethral route with the ultrasonic probe of the present invention, the sheath must be of a sufficient length to protect the tissue of the urethra, of a sufficient outside diameter to facilitate insertion of the sheath into the urethra, and a sufficient inside diameter capable of accepting the probe. By contrast, for tissue remodeling near, for example, the eye, a probe useful for such a procedure would be significantly shorter and of a significantly smaller diameter, and as such, so would the sheath. The exact dimensions of the sheath including its length and diameter is determined by requirements of a specific medical procedure. Similarly, as illustrated in FIGS. 3 and 4, the position and size of the sheath aperture 111 , or number and positions of the fenestrations 111 , or the presence of a bevel on the sheath terminus 129 to provide a means for tissue manipulations, will likewise be determined by the type of procedure, and the requirements of the particular patient.

In one aspect of the invention, as shown in FIG. 5, the sheath comprises an inner sheath 121 and an outer sheath 108 . The outer sheath may be connected to a retraction trigger (not shown), by one or more articulation means, such as wires, which is capable of moving the outer sheath with respect to the inner sheath. Each wire comprises a first end and a second end. The first end is affixed to the outer sheath 108 , while the second end is affixed to a retraction trigger. When the outer sheath 108 is slid back away from the terminus of the inner sheath 121 the tissues are exposed to cavitation energy emitted by the probe.

In another embodiment, the sheath is flexible. Articulation wires (not shown) comprising two ends, are connected to the sheath and an articulation handle. When the articulation handle is manipulated, for example, pulled axially inward, the flexible sheath will bend or articulate in a bending or articulation direction A, thereby causing the ultrasonic probe to bend or articulate in articulation direction A. In this way, the ultrasonic probe can be used to reach locations that are not axially aligned with the lumen or vessel through which the sheath and probe are inserted.

A particular advantage of the ultrasonic probe operating in transverse mode is that the efficient cavitation energy produced by the probe disintegrates target tissue to small particles of approximately 5 microns in diameter. Because of the operation of the probe, tissue debris created at the probe tip is propelled in a retrograde direction from the probe tip. Accordingly, in another embodiment of the invention, the sheath provides at least one aspiration channel, which can be adapted to a vacuum or suction device, to remove the tissue debris created by the action of the probe. The aspiration channel can be manufactured out of the same material as the sheath provided it is of a sufficient rigidity to maintain its structural integrity under the negative pressure produced by the aspiration means, for example a vacuum pump or other source of negative pressure. Such an aspiration channel is provided either inside the lumen of the sheath, or along the exterior surface of the sheath, or both. In these embodiments, the aspiration channel can be a second hollow sheath nested within the first sheath, or the aspiration channel can be formed in the body of the sheath. A preferred embodiment is shown in FIGS. 6 and 7, whereby the probe 22 itself has one or more grooves defining one or more aspiration channels 60 , and aspiration of tissue debris is effectuated along the probe length between the interior surface of the sheath and the exterior surface of the probe, as directed by the aspiration channels and by retrograde flow from the probe action. FIG. 6 shows a longitudinal cross-section of a portion of an ultrasonic probe 22 and tip 23 according to one embodiment of the invention, comprising a central irrigation passage 17 and lateral irrigation lumens 19 , as well as external aspiration channels 60 . The sheath, not shown, would surround the probe.

In another embodiment, the sheath of the present invention comprises an irrigation channel. The sheath is adapted to an irrigation means, for example, a peristaltic pump or other such device for delivering liquids under controlled flow rates and pressures, and the sheath directs fluid to the location of the probe. The irrigation channel can be manufactured out of the same material as the sheath provided it is of a sufficient rigidity to maintain its structural integrity under the positive pressure produced by the flow of fluid produced by the irrigation means. Such an irrigation channel is provided either inside the lumen of the sheath, or along the exterior surface of the sheath, or both. In these embodiments, the irrigation channel can be a second hollow sheath nested within the first sheath, or the irrigation channel can be formed in the body of the sheath. In one embodiment, the probe itself has one or more grooves defining irrigation channels, and fluid is directed along the probe length between the interior surface of the sheath and the exterior surface of the probe, as directed by the irrigation channels. In this embodiment, irrigation fluids provide a means of cooling the probe. The sheath itself, or an irrigation sheath contained within the first sheath can provide a means of introducing a drug or pharmaceutical formulation to the site of probe activity. For example, anti-thrombolytic drugs such as heparin, streptokinase, tPA, urokinase, hirulog, or hirudin may be introduced to the site of a vascular occlusion through the sheath. The ultrasonic energy further provides a means for assisting the drug in penetrating the occlusion.

In yet another embodiment, the sheath of the present invention further comprises both an irrigation and an aspiration channel. As in the above embodiments, the channels may be located within the sheath lumen, or exterior to the sheath, or a combination of the two, and can be proximal or distal to the other channel provided they are not in direct communication. Likewise, in these embodiments the probe itself has a plurality of grooves defining aspiration channels and irrigation channels, and fluid is directed along the probe length between the interior surfaces of the sheaths and the exterior surface of the probe, as directed by the aspiration and irrigation channels. In another aspect of the invention, the sheath comprises a means for directing, controlling, regulating, and focussing the cavitation energy emitted by the probe, an aspiration means, an irrigation means, or any combination of the above.

In yet another embodiment, as shown in FIG. 8, the sheath is a device that allows for the manipulation of tissues, comprising a surface that is capable of manipulating tissues near the site of the probe. In this aspect, the terminus of the sheath may be closed, such that the sheath insulates tissues from the destructive energy emitted by the probe and can be used to push tissues away from the aperture 111 , thereby allowing proximal tissues to be exposed to the probe 22 and 23 . Alternatively, the sheath comprises a beveled or arcutate surface at the sheath terminus 129 , capable of providing a means for hooking, grasping, or otherwise holding a tissue in proximity to the probe 22 and 23 . In another embodiment, the sheath allows for the introduction of another surgical device, for example, flexible biopsy forceps, capable of manipulating tissues into a tissue space, such that the surgical device can hold the tissue in proximity with the probe.

In a further embodiment, the internal surface of the sheath provides a means to amplify or focus cavitation energy from the probe 22 . In this aspect, the interior surface of the sheath comprises at least one structure or reflective element 118 , that extends into the sheath lumen. The reflective element maybe planar, or arcutate, or a combination of these shapes. Reflective elements of the present invention may be fabricated from the same material as the sheath, or may use different materials that optimize the reflective properties of the elements. Since the cavitation energy reaches a maximum at anti-nodes along the probe, the interval of the anti-nodes being determined by the ultrasonic frequency at which the generator operates, the spacing of the reflective elements in the sheath is determined by the intended operating frequency of the ultrasonic device. Similarly, the number of anti-nodes along the probe 22 , is determined by the length of the probe and the frequency. As such, the number of reflective elements is determined by the length of the probe and the operating frequency. For example, an ultrasonic device operating at a frequency of approximately 25 kHz employing a probe with a length at the thinnest interval 22 of about 3 centimeters, will display about seven anti-nodes approximately 2 millimeters wide, spaced about 2 millimeters apart. Energy will radiate circumferentially around the probe at these anti-nodes. A sheath useful with such a probe would comprise, for example but not limited to, a cylindrical sheath about at least 3 centimeters in length further comprising seven reflective elements, approximately 2 millimeters wide, spaced about 2 millimeters apart, positioned with respect to the probe such that the reflective elements 118 , are centered over the anti-nodes. Since the energy emitted by the probe radiates circumferentially from an anti-node, the reflective elements can extend radially from the interior, wall of the sheath into the sheath lumen, for example, 270 degrees around the interior of the sheath, while the remaining 90 degrees has no reflective element and thereby provides a means for channeling the cavitation energy from the anti-node to a position distal to the anti-node. The channeling means of the present example maybe a region where no reflective element is present, or where the shape or angle is altered compared to the reflective element, or any other such means of directing energy from the area of the anti-node to a position distal to the anti-node.

The sheath of the present invention may comprise a means of viewing the site of probe action. This may include an illumination means and a viewing means. In one embodiment, the sheath of the present invention comprises a means for containing or introducing (if external to the sheath) an endoscope, or similar optical imaging means. In another embodiment of the invention, the ultrasound medical device is used in conjunction with an imaging system, for example, MRI, or ultrasound imaging—in particular color ultrasound. In this embodiment, the action of the probe echogenically produces a pronounced and bright image on the display. The sheath in this embodiment shields the probe, thereby reducing the intensity of the probe image and enhancing the resolution of the image by decreasing the contrast between the vibrating probe and the surrounding tissues.

In yet another embodiment, the sheath assembly of the present on may be provided along with an ultrasonic probe in the form of a kit. In this aspect, the probe for a particular surgical procedure is provided, along with the correct sheath, as well as instructions for assembling and tuning the probe, and the appropriate frequency range for the procedure. The probe and sheath may be packaged preassembled, such that the probe is already contained within the sheath and the respective position of the probe within the sheath is optimized such that any reflective elements in the sheath would be correctly aligned with the prospective position of the anti-nodes for a given frequency, the kit further comprising instructions for the appropriate frequency. The kit may further comprise packaging whereby the probe and sheath are pre-sterilized, and sealed against contaminants. In a preferred embodiment, the probe and sheath are provided in a container that complies with regulations governing the storage, handling, and disposal of sharp medical devices. Such a container is capable of receiving and securing the probe and sheath before and after use. In one aspect, the sharps container provides a means of affixing the probe and sheath assembly to an ultrasonic medical device without direct manipulation of the probe and sheath assembly, and a means for removing the assembly from the ultrasonic medical device after use. In another aspect, the kit comprises a probe and sheath assembly contained within a sterile sharps container that further comprises a single use locking means, whereby the probe and sheath assembly is affixed to the ultrasonic medical device solely through the sharps container, are removed from device solely through the container, and once removed can not be re-extracted from the sharps container.

Referring now to FIG. 1, a transverse mode ultrasonic medical device comprising an elongated probe 6 which is coupled to a device providing a source or generation means for the production of ultrasonic energy (shown in phantom in the Figure as 66 ) constructed in accordance with the present invention is illustrated. The generation source may or may not be a physical part of the device itself. The probe 6 transmits ultrasonic energy received from the generator along its length. The probe is capable of engaging the ultrasonic generator at one terminus with sufficient restraint to form an acoustical mass that can propagate the ultrasonic energy provided by the generator. The other terminus of the probe comprises a tip 22 , which has a small diameter, enabling the tip to flex along its longitude. In one embodiment of the invention, the probe diameter decreases at defined regional or segment intervals 14 , 18 , 20 , and 22 . Energy from the generator is transmitted along the length of the probe, causing the probe segments 22 and 23 at the distal end to vibrate in a direction that is transverse to the probe longitudinal axis. In this embodiment, one of the probe intervals 18 has at least one groove 45 for engaging the locking assembly of a probe disposal container.

Referring now to FIG. 2, the terminal segment 22 and tip 23 of the probe are illustrated, wherein transverse vibration caused by application of ultrasonic energy to the probe generates alternating areas of maximum vibration, or “anti-nodes” 24 , along the length of the probe segment 22 and tip 23 , and “nodes,” or areas of minimum vibration 25 , at repeating intervals along said segment and tip. The number of anti-nodes, and their spacing along the probe depends on the frequency of the energy produced by the ultrasonic generator, while the separation of nodes and anti-nodes is a function of harmonic intervals of the frequency, and can be affected by tuning the probe. In a properly tuned probe, the anti-nodes will be found at a position exactly one half of the distance between the nodes. Tissue-destroying effects of the device are not limited to regions coming into direct contact with probe tip 23 , but rather, as the probe is moved through the area where ablation is desired, tissue is removed in areas adjacent to the multiplicity of anti-nodes produced along the entire length of the probe. The magnitude of the cavitation energy produced by the probe tip is such that it extends outward from the probe tip at the anti-nodes from about 1-2 millimeters.

Referring now to FIGS. 3 a - g , sheath assemblies comprising different configurations of dampening sheaths for the ultrasonic probe 6 are illustrated. FIG. 3 a shows a transverse mode probe 6 is shown comprising a semi-cylindrical sheath 107 , which partially contains the probe. For purposes of illustration, the probe 6 is visible beneath the sheath. The sheath 107 is of a sufficient diameter, so as to at least partially encompass the probe. In the semi-cylindrical embodiment shown, the circumference of the sheath is approximately 180 degrees, and the length is sufficient to span a plurality of intervals 20 and 22 over the probe. FIG. 3 b shows a semi-cylindrical sheath 107 (also shown in FIG. 2), and a second concentric sheath 108 that is cylindrical, and is capable of containing the first sheath 107 , as well as the probe 6 . FIG. 3 c shows the sheath 121 having a cylindrical structure of a sufficient diameter to contain the probe 6 , made visible for the purpose of illustration. Sheath 121 comprises at least one fenestration 111 , which allows the cavitation energy emitted from the probe tip to be communicated to an area outside the sheath, through the said fenestration; probe energy from areas wherein the probe is not exposed by a fenestration is contained by the sheath. FIG. 3 d shows the hollow cylindrical sheath 121 containing a plurality of arcutate fenestrations 111 . FIG. 3 e illustrates a longitudinal view of probe 6 contained within a sheath 121 which comprises a plurality of arcutate fenestrations 111 , and at least one acoustic reflective element 122 , that is adapted to the interior surface of the sheath. FIG. 3 f shows a sheath 121 further comprising two semi-cylindrical halves 109 , each half connected to the other by one or more connecting means 113 . The probe 6 is capable of being substantially contained within the sheath. The cavitation energy generated by the probe tip 22 is contained by the semi-cylindrical halves 109 , where they occlude the probe tip. FIG. 3 g illustrates a sheath further comprising of at least two cylinders 104 , each cylinder connected to the other by at least one connecting means 113 . The probe 6 is capable of being substantially contained within the sheath. The cavitation energy generated by the probe tip 22 is contained by cylinders 104 , where they occlude the probe tip.

Referring now to FIG. 4, a segment 20 of a probe is substantially contained in a sheath 121 comprising a plurality of fenestrations 111 . Release of cavitation energy emitted by the probe 20 , to the environment is controlled by sheath 121 and is communicated to the outside of the sheath through the fenestrations.

Referring now to FIG. 5, the distal end of the probe of ultrasonic medical device contained in a sheath assembly is illustrated. The probe 6 is substantially contained within a cylindrical sheath 121 capable of modulating the energy omitted by an active probe, and shielding tissues from puncture from a sharp probe tip. The sheath 121 shown in this illustration has been modified such that one of the terminal ends of the sheath is substantially open, defining a fenestration or aperture 111 , which exposes the probe tip 22 and 23 . The terminus of the sheath 129 is shaped to provide a means for manipulating tissue to bring it into proximity with the probe 22 and 23 . A second concentric cylindrical sheath 108 which surrounds a portion of the first sheath 121 , that can be manipulated longitudinally along the first sheath to provide a means for modulating the exposure of the probe tip 22 and 23 by partial closure of the aperture 111 , thereby modulating the cavitation energy emitted by the probe to which occlusion materials will be exposed.

Referring now to FIG. 6, a longitudinal cross-section of a portion of an ultrasonic probe tip 22 and 23 is shown, comprising a central irrigation passage 17 , lateral irrigation lumens 19 , and as external aspiration channels 60 .

Referring now to FIG. 7, a transverse cross-sectional view of a portion of the ultrasonic probe shown. The probe 6 comprises a plurality of arcutate channels 60 that extend over the longitudinal length of the probe tip, providing a conduit for irrigation and or aspiration of tissue debris and fluid.

Referring now to FIG. 8, sheath comprising a fenestration 111 allowing communication of the cavitation energy emitted by the probe to the outside of the sheath is shown. The interior of the sheath further comprises reflective elements 118 , shown as a plurality planar surfaces that extend from the interior wall of the sheath into the lumen, thereby providing a means for focusing and redirecting cavitation energy emitted by the probe tip. In embodiment, the terminus of the sheath 129 is shaped to provide a tissue manipulation means.

Referring now to FIG. 9, a sheath comprising a fenestration 111 allowing communication of the cavitation energy emitted by the probe to the outside of the sheath is shown. The interior of sheath 121 containing the probe 22 and 23 comprises reflective elements 118 that are arcuate, and contain a plurality of fenestrations 111 .

Sheath materials useful for the present invention include any material with acoustical or vibrational dampening properties capable of absorbing, containing, or dissipating the cavitation energy emitted by the probe tip. Such materials must be capable of being sterilized by, for example, gamma irradiation or ethylene oxide gas (ETO), without losing their structural integrity. Such materials include but are not limited to, plastics such as polytetrafluoroethylene (PTFE), polyethylene, polypropylene, silicone, polyetherimide, or other such plastics that are used in medical procedures. Ceramic materials can also be used, and have the added benefit that they may be sterilized by autoclaving. Combinations of the aforementioned materials can be used depending on the procedure, for example as in the sheath of FIG. 5, a ceramic sheath 121 can be used in combination with a moveable PTFE outer sheath 108 . Alternatively a single sheath may employ two or more materials to give the desired combination of strength and flexibility, for example, the sheath may comprise a rigid ceramic section distal to the probe tip 23 and a more flexible plastic section proximal to the tip, capable of flexing with the probe 22 . In the currently preferred embodiment of the invention, PTFE is used to fabricate a strong, flexible, disposable sheath that is easily sterilized by irradiation or ETO gas.

It should be obvious to those of ordinary skill in the art that the individual features described herein may be combined. Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and scope of the invention as claimed. Accordingly, the invention is to be defined not by the preceding illustrative description but instead by the spirit and scope of the following claims.





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